What are the responsibilities and job description for the Quality Systems Audit Manager position at Catalent Pharma Solutions?
About Catalent
Catalent is a global leader in the development and manufacturing of new treatments for patients worldwide. Our mission is to help people live better, healthier lives.
We are seeking an experienced Quality Systems Audit Manager to join our team at our Harmans/BWI facility in Maryland. This role will be responsible for managing and overseeing our core quality systems, including investigation/deviation management, CAPA tracking, change control, risk management, and quality metric tracking.
Responsibilities:
- Manage QA staff supporting investigation/deviation/CAPA management, change control, risk management, and quality metric tracking responsibilities
- Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhere to safety guidelines
- Oversee daily activity for the group to ensure quality results and performance management for direct reports
- Administer investigation and deviation systems for tracking statuses, follow-up, and liaison with applicable department investigation writers to ensure complete and timely resolution
- Administer CAPA Tracking System for general GMP use and internal audits
- Track the timely completion and extension of commitments, perform trending review of deviations and investigations, compile report, and identify trends or areas requiring additional actions
- Administer change control system for tracking and coordinating the initiation, execution, and completion of change controls
- Administer Risk Management system and track completion of risk assessments
- Compile pertinent QA metrics for Senior Management review
- Assemble critical metrics from applicable departments, analyze using appropriate tools to identify trends and report via a PowerPoint presentation to be reviewed by Senior Management on a periodic basis
- Track action items for completion
- Support client projects and provide quality oversight of manufacturing operations and the release of drug substance and/or final drug product to support Phase I/II clinical trials
- Work closely with manufacturing, Facilities, and Quality Control staff to resolve quality issues with regard to the facilities and product manufactured
- Proactively partner with Human Resources to attract and retain top talent and take an active role in ensuring new employee onboarding is a success
Requirements:
- Masters degree in a Scientific, Engineering, or Biotech field with 6 years experience within the biologic, pharmaceutical, or medical device industry performing direct hands-on work in a Quality Assurance/Quality Control function with a strong familiarity of general GMP documentation
- Bachelors degree in a Scientific, Engineering, or Biotech field with 8 years experience within the biologic, pharmaceutical, or medical device industry performing direct hands-on work in a Quality Assurance/Quality Control function with a strong familiarity of general GMP documentation
- 2 years Progressive Leadership experience, experience with Performance Management, Goal Setting, and Managing through Conflict
- Demonstrable leadership experience at Catalent may be considered in place of external experience
- Experience with Good Manufacturing Practices (GMPs) and 21 CFR Parts 210 and 211 or Quality System regulations (QSR) per 21 CFR Part 820
- ASQ CQA (American Society of Quality Certified Quality Auditor) highly desirable
- Expert knowledge of biological regulations (21 CFR Part 600s) or EU GPs, a plus
- SME/Expert in all Microsoft Applications, i.e., EXCEL, PowerPoint, Access, Teams, and Sharepoint; proficient with electronic systems, including developing and producing reports; experience with data analytics and concepts
